Part 11, Electronic Records; Electronic Signatures
Sometimes it may be difficult to differentiate between analog and digital circuits as they have elements of both linear and non-linear operation. An example is the comparator which takes in a continuous range of voltage but only outputs one of two levels as in a digital circuit. Similarly, an overdriven transistor amplifier can take on the characteristics of a controlled switch having essentially two levels of output. In fact, many digital circuits are actually implemented as variations of analog circuits similar to this example – after all, all aspects of the real physical world are essentially analog, so digital effects are only realized by constraining analog behavior. As an outgrowth of its current good manufacturing practice initiative for human and animal drugs and biologics,4 FDA is re-examining part 11 as it applies to all FDA regulated products. We anticipate initiating rulemaking to change part 11 as a result of that re-examination. While the re-examination of part 11 is u